DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
3. Claims 1-3, 9, 13-15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 2020/0016374 A1) (hereafter “Burkholz”) in view of Bak (WO 2021/028595).
Regarding Claim 1, Burkholz discloses a catheter system (the catheter assembly 62, Para [0062], Fig.6), comprising: an intravenous catheter assembly (Fig.6 shows catheter 62 is an intravenous catheter assembly) comprising: a catheter (catheter assembly 62, which may include a catheter adapter 64 and a catheter 65, Para [0062], Fig.6) comprising a distal end (Fig.6 shows the distal end of catheter 65 near tip 85) and a proximal end (Fig.6 shows the proximal end of catheter 65 near 70), the catheter defining a lumen extending between the distal end and the proximal end (all catheters inherently have a lumen that extend between the distal and proximal end, In Fig.6, the lumen of the catheter is between the tip 85 and the proximal end near 70); and an access connector (the catheter assembly 62 may include a connector 82, Para [0065], Fig.6) configured to provide access to the lumen of the catheter (Fig.6 shows the connector 82 is connected to the lumen of the catheter through the side port 72); and a disinfecting probe (the delivery device 10, Para [0061], Fig.1A, It is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe a light tube for disinfection, or another suitable instrument, Para [0068], so device 10 can be a disinfection probe) coupleable to the access connector (Fig.6 shows the delivery device 84 connected to the catheter through the connector 82, the delivery device 84 may include or correspond to the one or more of the following: the delivery device 10, Para [0061], so device 10 can be connected through the connector 82 [access connector]), the disinfecting probe comprising: a housing (housing (housing 14, Para [0044], Fig.1A) having a proximal end (proximal end 18 of the housing, Para [0044], Fig.1A) and a distal end (the distal end 16, Para [0044], Fig.1A); a lighting system (a guide feature 22, which may be disposed within the housing 14, Para [0034], In some embodiments, a guidewire 34 may be disposed within the catheter 12. It is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe, a light tube for disinfection, or another suitable instrument, Para. [0068], the first end 36 of the guidewire 34, Para [0066], so the guide wire 34 can be a lighting system) disposed at least partially within the housing (Fig.1A shows guidewire 34 within the housing 14) and an advancement member configured to advance a portion of the lighting system beyond the distal end of the housing and into the catheter (when the guide feature 22 is fully advanced in the distal direction 23 to fully advance the instrument and/or the guidewire 34, Para [0047]. the guide feature 22 maybe moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25, Para [0034], in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, Para [0037], Fig.1B, so the guidewire 34 can extend through end 28 and into the catheter through the connector as shown in Fig.6), responsive to movement of the advancement member with respect to the housing (in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, Para [0037], the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user. Para [0034], the advancement tab 26 may be disposed on a top, side, or bottom of the delivery device 10, Para [0035], so the guidewire 34 moves in response to the advancement tab 26 with respect to housing 14) wherein the disinfecting light disinfects the lumen of the catheter upon being advanced therein by the advancement member (In some embodiments, the instrument may include a probe, a light tube for disinfection, or another suitable instrument, which may be placed into the second catheter via the delivery device 10, Para [0032], the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user, Parа [0034], when the guide feature 22 is fully advanced in the distal direction 23 to fully advance the instrument and/or the guidewire 34, Para [0047], in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, Para [0037], Fig.1B, so the guidewire 34 extends through end 28 and into the catheter through the connector as shown in Fig.6 thereby disinfecting the lumen of the catheter on which the guidewire is placed).
Burkholz fails to explicitly disclose the lighting system is configured to emit a disinfecting ultraviolet light.
Bak discloses a light guiding assembly (Abstract) with a the lighting system is configured to emit a disinfecting ultraviolet light (The light source assembly 12, Page 5, Para 4, Ln 30, Fig.1A, The light source, e.g. the LED, used for UVC disinfection purposes preferably has wavelengths in the UVC spectral range, i.e. 250-280 nm, Page 12, Para 4-5, Lns 31-32, so the light emitted from the light source is the disinfecting UVC light).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Burkholz with the teaching of Bak for the purpose of disinfecting narrow medical tubes such as endotracheal tubes and venous catheters (Bak, Page 5, Para 2, Lns 9-10).
Regarding Claim 2, modified Burkholz discloses the system of claim 1, wherein the access connector comprises a needleless access connector (Fig.6 shows connector 82 is a needless access connector), and wherein the disinfecting probe comprises a blunt cannula (the delivery device 10 may include a connector 40, which may be disposed at the distal end 16 of the housing 14, the connector 40 may be configured to couple the delivery device 10 to the intravenous catheter assembly. In some embodiments, the connector 40 may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector, Para [0044], Fig.1, so connector 40 can be a replaced by a blunt cannula) at the distal end of the housing (the delivery device 10 may include a connector 40, which may be disposed at the distal end 16 of the housing 14. Para [0044], Fig.1B) that is reversibly coupleable to the needleless access connector (Fig.6 shows connector 40 connected to the connector 82; since connector 40 is a blunt cannula, it is possible to connect through both sides reversibly to 82) and wherein the advancement member is configured to advance the portion of the lighting system through the blunt cannula and the needleless access connector, into the lumen of the catheter (it is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe, a light tube for disinfection, or another suitable instrument, Para [O068], so the guidewire 34 [guidewire 36 is the first end of the guidewire 34] can be a lighting system that moves in response to the advancement tab 26. The advancement tab 26 is used to advance or retract the lighting system [guide wire 34 or optical fiber] through the connectors 40 and 82 into the lumen of the catheter).
Regarding Claim 3, modified Burkholz discloses the system of claim 1, wherein the advancement member is configured to advance a portion of the optical fiber beyond the distal end of the housing (the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user, Para [0034], Fig.1A.when the guide feature 22 is fully advanced in the distal direction 23 to fully advance the instrument and/or the guidewire 34, Para [0047].the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25, Para [0034], in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, Para [0037], Fig.1B, so the guidewire 34 can extend through end 28 and into the catheter through the connector as shown in Fig.6. It is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe, a light tube for disinfection, or another suitable instrument, Para [0068], so the guidewire can be an optical fiber that can be advanced further than the distal end of the housing)
Burkholz fails to explicitly disclose wherein the lighting system comprises an ultraviolet light source positioned adjacent the proximal end of the housing and configured to emit the disinfecting ultraviolet light; and an optical fiber extending out distally from the ultraviolet light source and configured to transmit the disinfecting ultraviolet light along a length of the optical fiber.
Bak teaches a light guiding assembly (Abstract) wherein the lighting system comprises: an ultraviolet light source (The light source assembly 12, Page 5, Para 4, Ln 30, Fig.1A, the light source is an LED emitting light in the range 250-600 nm, Page 13, Para 4, Ln 25) positioned adjacent the proximal end of the housing (Fig.1A shows the light source 12 is near the proximal end) and configured to emit the disinfecting ultraviolet light (The light source assembly 12, Page 5, Para 4, Ln 30, Fig.1A, the light source is an LED emitting light in the range 250-600 nm, Page 13, Para 4, Ln 25, so the light source is capable of emitting UV light for disinfection); and an optical fiber extending out distally from the ultraviolet light source (The optical fiber is preferably made of a glassy material, such as UV grade quartz or fused silica. The fiber can preferably be connected to the light source 12, The optical fiber might be fastened and centered in the connector part 50 and forced up to the edge of the window 36. Page. 13, Para 5, Lns 31-35, Fig.2A) and configured to transmit the disinfecting ultraviolet light along a length of the optical fiber (The optical fiber could be surface treated such that there is a loss of light along the length of the fiber. The fiber could be protected by encapsulating it in a transparent polymer sleeve, Page 13, Para 5, Ln 35, Page 14, Para 1, Lns1-2, so the fiber transmits UV light through the length of the optical fiber).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Burkholz with the teachings of Bak for the purpose of coupling a small and compact light source, such as an LED, with a small diameter lens system to a light guiding element that allows focusing and propagation of UV light (Bak, Page 4, Para 3, Lns 29-31) thereby making it possible to disinfect narrow medical tubes such as endotracheal endotracheal tubes and a venous catheters (Bak, Page 5, Para 2, Lns 9-10).
Regarding Claim 9, modified Burkholz discloses the system of claim 1, wherein the advancement member is configured to move along an outer surface of the housing (the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user – see Para [0034], Fig.1A, tab 26 is on the outer surface of the housing and moved by a user), and wherein the advancement member engages the lighting system to advance the portion of the lighting system beyond the distal end of the housing and into the catheter (when the guide feature 22 is fully advanced in the distal direction 23 to fully advance the instrument and/or the guidewire 34, see Para [0047], the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25, see Para [0034], in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, see Para [0037], Fig.1B, so the guidewire 34 can extend beyond end 28 and into the catheter through the connector, Fig.6).
Regarding Claim 13, Burkholz discloses a disinfecting probe (the delivery device 10, Para [0061], Fig.1A, It is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe a light tube for disinfection, or another suitable instrument, Para [0068], so device 10 can be a disinfection probe) for disinfecting a catheter of an intravenous catheter assembly (Fig.6 shows catheter 62 is an intravenous catheter assembly), the disinfecting probe comprising: a housing (housing 14, Para [0044], Fig.1A) having a proximal end (proximal end 18 of the housing, Para [0044], Fig.1A) and a distal end (the distal end 16, Para [0044], Fig.1A); a lighting system (a guide feature 22, which may be disposed within the housing 14, Para [0034], In some embodiments, a guidewire 34 may be disposed within the catheter 12. It is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe, a light tube for disinfection, or another suitable instrument, Para [0068], the first end 36 of the guidewire 34, Para [0066], so the guide wire 34 can be a lighting system) disposed at least partially within the housing (Fig.1A shows guidewire 34 within the housing 14) and an advancement member (the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user. Para [0034], Fig.1A) configured to advance a portion of the lighting system beyond the distal end of the housing and into the catheter (when the guide feature 22 is fully advanced in the distal direction 23 to fully advance the instrument and/or the guidewire 34, Para [0047], the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25, Para [00341, in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, Para [0037], Fig.1B, so the guidewire 34 can extend through end 28 and into the catheter through the connector as shown in Fig.6) responsive to movement of the advancement member with respect to the housing (in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, Para [0037], the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user. Para [0034], the advancement tab 26 may be disposed on a top, side, or bottom of the delivery device 10, Para [0035], so the guidewire 34 moves in response to the advancement tab 26 with respect to housing 14); wherein the disinfecting light disinfects a lumen of the catheter upon being advanced therein by the advancement member (In some embodiments, the instrument may include a probe, a light tube for disinfection, or another suitable instrument, which may be placed into the second catheter via the delivery device 10, Para [00321, the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user. Para [0034], when the guide feature 22 is fully advanced in the distal direction 23 to fully advance the instrument and/or the guidewire 34, Para [0047]. in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, Para [0037], Fig.1B, so the guidewire 34 extends through end 28 and into the catheter through the connector as shown in Fig.6 thereby disinfecting the lumen of the catheter on which the guidewire is placed).
Burkholz fails to explicitly disclose the lighting system is configured to emit a disinfecting ultraviolet light.
Bak teaches a light guiding assembly (Abstract) with a the lighting system is configured to emit a disinfecting ultraviolet light (The light source assembly 12, Page 5, Para 4, Ln 30, Fig.1A, The light source, e.g. the LED, used for UVC disinfection purposes preferably has wavelengths in the UVC spectral range, i.e. 250-280 nm, Page 12, Para 5, Lns 31-32, so the light emitted from the light source is the disinfecting UVC light).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz with the teaching of Bak for the purpose of disinfecting narrow medical tubes such as endotracheal tubes and venous catheters (Bak, Page 5, Para 2, Lns 9-10).
Regarding Claim 14, modified Burkholz discloses the disinfecting probe of claim 13, further comprising a blunt cannula (the delivery device 10 may include a connector 40, which may be disposed at the distal end 16 of the housing 14. the connector 40 may be configured to couple the delivery device 10 to the intravenous catheter assembly. In some embodiments, the connector 40 may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector. Para [0044], Fig.1B, so connector 40 can be a replaced by a blunt cannula, delivery device 10 is the disinfection probe) positioned at the distal end of the housing (the delivery device 10 may include a connector 40, which may be disposed at the distal end 16 of the housing 14. Para [0044], Fig. 1B), the blunt cannula reversibly coupleable to a needleless access connector of the intravenous catheter assembly (Fig.6 shows connector 40 connected to the connector 82. since connector 40 is a blunt cannula, it is possible to connect through both sides reversibly to 82); wherein the advancement member is configured to advance the portion of the lighting system through the blunt cannula and the needleless access connector, into the lumen of the catheter (It is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe, a light tube for disinfection, or another suitable instrument, Para [0068], so the guide wire 34 [guidewire 36 is the first end of the guidewire 34] can be a lighting system that moves in response to the advancement tab 26. The advancement tab 26 is used to advance or retract the lighting system [guide wire 34 or optical wire] through the connectors 40 and 82 into the lumen of the catheter).
Regarding Claim 15, modified Burkholz discloses the disinfecting probe of claim 13, wherein the advancement member is configured to advance a portion of the optical fiber beyond the distal end of the housing (the guide feature 22 may include an advancement tab 26, which hic may be configured to be moved by a hand of a user. Para [0034], Fig.1A.when the guide feature 22 is fully advanced in the distal direction 23 to fully advance the instrument and/or the guidewire 34, Para [0047], the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25, Para [0034], in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may, be advanced distally, Para [0037], Fig.1B, so the guidewire 34 can extend through end 28 and into the catheter through the connector as shown in Fig.6. It is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe, a light tube for disinfection, or another suitable instrument, Para [0068], so the guidewire can be an optical fiber that can be advanced further than the distal end of the housing).
Burkholz fails to explicitly disclose wherein the lighting system comprises: an ultraviolet light source positioned adjacent the proximal end of the housing and configured to emit the disinfecting ultraviolet light; and an optical fiber extending out distally from the ultraviolet light source and configured to transmit the disinfecting ultraviolet light along a length of the optical fiber.
Bak teaches a light guiding assembly (Abstract) wherein the lighting system comprises: an ultraviolet light source (The light source assembly 12, Page 5, Para 4, Ln 30, Fig.1A, the light source is an LED emitting light in the range 250-600 nm, Page 13, Para 4, Ln 25) positioned adjacent the proximal end of the housing (Fig.1A shows the light source 12 is near the proximal end) and configured to emit the disinfecting ultraviolet light (The light source assembly 12, Page 5, Para 4, Ln 30, Fig.1A, the light source is an LED emitting light in the range 250-600 nm, Page 13, Para 4, Ln 25, so the light source is capable of emitting UV light for disinfection); and an optical fiber extending out distally from the ultraviolet light source (The optical fiber is preferably made of a glassy material, such as UV grade quartz or fused silica. The fiber can preferably be connected to the light source 12, The optical fiber might be fastened and centered in the connector part 50 and forced up to the edge of the window 36. Page 13, Para 5, Lns 31-35, Fig.2A) and configured to transmit the disinfecting ultraviolet light along a length of the optical fiber (The optical fiber could be surface treated such that there is a loss of light along the length of the fiber. The fiber could be protected by encapsulating it in a transparent polymer sleeve, Page 13, Para 5, Ln 35, Page 14, Para 1, Lns1-2, so light is transmitting UV light through the length of the optical fiber). I
Therefore, it would have been obvious to one of ordinary skill in the art before the priority date to modify Burkholz with the teaching of Bak for the purpose of coupling a small and compact light source, such as an LED, with a small diameter lens system to a light guiding element that allows focusing and propagation of UV light (Bak, Page 4, Para 3, Lns 29-31) thereby making it possible to disinfect narrow medical tubes such as endotracheal tubes and venous catheters (Bak, Page 5, Para.2, Lns 9-10).
Regarding Claim 21, modified Burkholz discloses the disinfecting probe of claim 13, wherein the advancement member (the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user, Para [0034], Fig. 1A) is configured to move along an outer surface of the housing (the advancement tab 26 may be disposed on a tap, side, or bottom of the delivery device 10, Para [0035], the guide feature 22 may include an advancement tab 28, which may be configured to be moved by a hand of a user, Para [0034], thus the advancement tab 26 Is constructed to move along the outer surface of housing 14) and wherein the advancement member engages the lighting system to advance the portion of the lighting system beyond the distal end of the housing and into the catheter (when the guide feature 22 Is fully advanced in the distal direction 23 to fully advance the instrument and/or the guidewire 34, Para [0047], the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 29 and/or retract the instrument in a proximal direction 28, Para [0034], in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally, Para [0037], Fig. 1B, see the guidewire 34 can extend through end 28 and into the catheter through the connecter as shown in Fig.6, ft is understood that in some embodiments, the catheter 12 and/or the guidewire 38 may be replaced with another instrument, such as, for example, 3 probe, a light tube for disinfection, or another suitable instrument, Para [0068], so the guide wire 34 (guidewire 36 is the first end of the guidewire 34) can be a light tube for disinfection).
4. Claims 4-5, 10-11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Bak as applied to claims 1, 3 and 15 above, and further in view of Tang et al. (US 2019/0192814 A1) (hereafter “Tang”).
Regarding Claim 4, modified Burkholz discloses the system of claim 3. Burkholz fails to explicitly disclose wherein the lighting system comprises a cladding covering a portion of the optical fiber and that is configured to block transmission of the disinfecting ultraviolet light.
Tang teaches a device (Abstract) wherein the lighting system comprises a cladding covering a portion of the optical fiber (the one or more optical fiber 240 is constructed of a light transmissive core material having a relatively high index of refraction and surrounded by a cladding material having a relatively lower index of refraction, Para [0042], the cladding material may be a translucent, light-absorptive or opaque cladding material. Para [0042], so the cladding material covers a portion of the light transmissive core of the optical fiber) and that is configured to block transmission of the disinfecting ultraviolet light (the cladding material may be a translucent, light-absorptive or opaque cladding material, Para [0042], so the cladding can be of light absorptive opaque material that block transmission of light, the one or more optical fibers 240 contained in the tubular member 200 may be in the form of one or more optical fiber bundles. The optical fibers within fiber bundles may be of different lengths and diameters and exhibit different leakage rates of UV light. Para [0041], the UV source 310 transmits UV light having a wavelength between about 260 nm and about 280 nm, the UV light is UVA, UVB and/or UVC light, Para [0055], so it is possible to cover a portion of the optical fiber to block UV light transmission).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Burkholz with the teaching of Tang for the purpose of controlling the direction and intensity of UV light applied to the device internals. The use of reflective materials allows the UV light transmitted through the optical fiber to be directed inward in order to irradiate intra-luminal regions where bacterial colonies tend congregate (Tang, Para [0030]).
Regarding Claim 5, modified Burkholz discloses the system of claim 4. Burkholz fails to explicitly disclose wherein the cladding covers a full length of the optical fiber except for a tip at a distal end of the optical fiber, such that the disinfecting ultraviolet light is emitted only from the tip. Tang teaches a device (Abstract) wherein the cladding covers a full length of the optical fiber except fora tip at a distal end of the optical fiber (the one or more optical fiber 240 is constructed of a light transmissive core material having a relatively high index of refraction and surrounded by a cladding material having a relatively lower index of refraction, Para [0042], so it is understood that the entire optical fiber is surrounded by the cladding material. the cladding material may be a translucent, light-absorptive or opaque cladding material, Para [0042]), such that the disinfecting ultraviolet light is emitted only from the tip (the UV source 310 transmits UV light having a wavelength between about 260 nm and about 280 nm, the UV light is UVA, UVB and/or UVC light, Para [0055], FIG.14 is a block diagram that illustrates a longitudinal cross-sectional view 1400 of an example tubular member 200, according to an embodiment, in which more than one non-diffusive optical fiber or bundle are contained within the lumen 1430. The tubular member 200 contains a UV reflective inner surface 1410 surrounded by a flexible catheter material 1405, that is UV absorbent in some embodiments. The distal end of the tubular member 200 contains an opening 1407, Para [0040], so the UV light is transmitted only at the opening 1407 at the distal tip).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz with the teaching of Tang for the purpose of reducing the light released (Tang, Para [0045]), thereby controlling the direction and intensity of UV light being applied to the device internals (Tang, Para [0008]).
Regarding Claim 10, modified Burkholz discloses the system of claim 1. Burkholz fails to explicitly disclose wherein the lighting system comprises a control system configured to selectively control emission of the disinfecting ultraviolet light, the control system comprising one or more of an on/off switch, a timer, and a communication device.
Tang teaches a device (Abstract) wherein the lighting system (a UV illumination system configuration 300, Para [0052]) comprises a control system (the UV illumination system 301 may also contain a controller 360, Para [0050]) configured to selectively control emission of the disinfecting ultraviolet light (the UV illumination system 300 may also contain a controller 360 adapted to provide on/off and intensity control of one or more UV sources 310, Para [0052]), the control system comprising one or more of an on/off switch, a timer and a communication device (the UV illumination system 300 may also contain a controller 360 adapted to provide on/off and intensity control of one or more UV sources 310, Para [0052], to provide on/off feature, the controller must have a switch and a timer, a socket 350 connects the UV source 310 to a power source 340 and a current controller 330. In some embodiments, the UV illumination system 300 may also contain a controller 360 adapted to provide on/off and intensity control of one or more UV sources 310, Para [0052], for the controller 360 to send signals to socket 350 and current controller, it must have a communication device in it to reduce or increase the current flowing).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz with the teaching of Tang for the purpose of controlling the direction and intensity of UV light that may be applied to the device internals (Tang, Para [0034]).
Regarding Claim 11, modified Burkholz discloses the system of claim 1. Burkholz fails to explicitly disclose wherein the lighting system is configured to emit UV-C light. The University of Maryland teaches a device (Abstract) wherein the lighting system is configured to emit UV-C light (the UV source 310 transmits UV light having a wavelength between about 260 nm and about 280 nm. In some embodiments the UV light is UVA, UVB and/or UVC light. The UV source 310 may be in the form of one or more LEDs, Para [0055]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz with the teaching of Tang for the purpose of transmitting UV light through at least one optical fiber to be directed inward in order to irradiate intra-luminal regions thereby killing bacteria (Tang, Para [0030]).
Regarding Claim 16, modified Burkholz discloses the disinfecting probe of claim 15. Burkholz fails to explicitly disclose wherein the lighting system comprises a cladding covering a portion of the optical fiber and that is configured to block transmission of the disinfecting ultraviolet light. Tang teaches a device (Abstract) wherein the lighting system comprises a cladding covering a portion of the optical fiber (the one or more optical fiber 240 is constructed of a light transmissive core material having a relatively high index of refraction and surrounded by a cladding material having a relatively lower index of refraction, Para [0042], the cladding material thus covers light transmissive core of the optical fiber) and that is configured to block transmission of the disinfecting ultraviolet light (the cladding material may be a translucent, light-absorptive or opaque cladding material, Para [0042], so the cladding can be light absorptive opaque material that block transmission of light, the one or more optical fibers 240 contained in the tubular member 200 may be in the form of one or more optical fiber bundles. The optical fibers within fiber bundles may be of different lengths and diameters and exhibit different leakage rates of UV light. Para [0041], the UV source 310 transmits UV light having a wavelength between about 260 nm and about 280 nm, the UV light is UVA, UVB and/or UVC light, Para [0055], so it is possible to cover a portion of the optical fiber to block UV light transmission).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz with the teaching of Tang for the purpose of controlling the direction and intensity of UV light applied to the device internals. The use of reflective materials allows the UV light transmitted through the optical fiber to be directed inward in order to irradiate intra-luminal regions where bacterial colonies tend congregate (Tang, Para [0030]).
Regarding Claim 17, modified Burkholz discloses the disinfecting probe of claim 16. Burkholz fails to explicitly disclose wherein the cladding covers a full length of the optical fiber except for a tip at a distal end of the optical fiber, such that the disinfecting ultraviolet light is emitted only from the tip. Tang teaches a device (Abstract) wherein the cladding covers a full length of the optical fiber except for a tip at a distal end of the optical fiber (the one or more optical fiber 240 is constructed of a light transmissive core material having a relatively high index of refraction and surrounded by a cladding material having a relatively lower index of refraction, Para [0042], so it is understood that the entire optical fiber is surrounded by the cladding material. The cladding material may be a translucent, light-absorptive or opaque cladding material. Para [0042]), such that the disinfecting ultraviolet light is emitted only from the tip (the UV source 310 transmits UV light having a wavelength between about 260 nm and about 280 nm, the UV light is UVA, UVB and/or UVC light, Para [0055], FIG.14 is a block diagram that illustrates a longitudinal cross-sectional view 1400 of an example tubular member 200, according to an embodiment, in which more than one non-diffusive optical fiber or bundle are contained within the lumen 1430.The tubular member 200 contains a UV reflective inner surface 1410 surrounded by a flexible catheter material 1405, that is UV absorbent in some embodiments. The distal end of the tubular member 200 contains an opening 1407, Para [0040]. so the UV light is transmitted only at the opening 1407 at the distal tip).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz with the teaching of Tang for the purpose of reducing the light released (Tang, Para [0045]), thereby controlling the direction and intensity of UV light being applied to the device internals (Tang, Para [0008]).
5. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Bak as applied to claim 1 above, and further in view of Matlock et al. (US 2021/0154450 A1) (hereafter “Matlock”).
Regarding Claim 12, modified Burkholz discloses the system of claim 1, with the advancement member (the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user, Para [0034], Fig.1A). Burkholz fails to explicitly disclose wherein the advancement member comprises a wheel member positioned on the housing and rotatable relative to the housing, wherein the wheel member is operably coupled to a lighting component of the lighting system, to advance and retract the lighting component out of and back into the housing when the wheel member is rotated.
Matlock teaches an apparatus (Abstract) wherein rein the advancement member comprises a wheel member (spin actuator 610 of the present example includes a plurality of thumbwheel engagement features 612, a proximal shaft 614, and a distal shaft 616. Para [0078], Fig.19) positioned on the housing and rotatable relative to the housing (Fig.1B shows the thumbwheel member [part of guide wire actuation assembly 600] is on the housing), wherein the wheel member is operably coupled to a lighting component of the lighting system (guidewire 602 includes one or more optical fibers or other light-communicating features, connector 604, Para [0077], Fig.17 shows the guidewire 602 is coupled operably to the spin actuator [wheel member]), to advance and retract the lighting component out of and back into the housing when the wheel member is rotated (the operator may advance guidewire actuation assembly 600 distally along handle assembly 500 to thereby advance guidewire 602 distally, Para [0055]. The guidewire [lighting component] can thus be advanced and retracted).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz with the teaching of Matlock for the purpose of positioning within the target area and then illuminated with light projecting from the distal end (Matlock, Para [0005]).
Allowable Subject Matter
6. Claims 6-8 and 18-20 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 6, the prior art of record, individually or in combination, does not teach or fairly suggest the system of claim 4, wherein the cladding covers a length of the optical fiber and includes openings formed therein at locations spaced apart along the length of the optical fiber, such that the disinfecting ultraviolet light is emitted from the optical fiber only at the locations. The closest prior art to the claimed invention is Tang whom describes a device with cladding material but does not describe openings formed along the length of the optical fiber to transmit UV light only at the openings.
Regarding Claim 7, the prior art of record, individually or in combination, does not teach or fairly suggest the system of claim 1, wherein the lighting system comprises: a guide wire; and a light strip mounted on the guide wire, the light strip comprising a plurality of ultraviolet light emitting diodes (LEDs) configured to emit the disinfecting ultraviolet light; wherein the advancement member is configured to advance a portion of the guide wire and the light strip beyond the distal end of the housing. The closest prior art to the claimed invention is Burwell et al. (US 2016/0213945 A1) whom describes a light generating apparatus where a guidewire lumen (98a, Fig. 9C) is disposed adjacent to light source array (97; FIG. 9D shows a linear array 96 including a plurality of light emitting sources that spirals around a guidewire lumen 98b, Para [0081]), but does not describe a light strip mounted on the guide wire having a plurality of ultraviolet LEDs configured to emit disinfecting UV light; and wherein the advancement member is configured to move forward a portion of the guide wire and the light strip out of the distal end.
Regarding Claim 8, the prior art of record, individually or in combination, does not teach or fairly suggest the system of claim 7, wherein the plurality of ultraviolet LEDs are equally spaced along a length of the light strip. The closest prior art to the claimed invention is Burwell et al. (US 2016/0213945 A1) whom describes a light generating apparatus where a guidewire lumen (98a, Fig. 9C) is disposed adjacent to light source array (97; FIG. 9D shows a linear array 96 including a plurality of light emitting sources that spirals around a guidewire lumen 98b, Para [0081]), but does not describe the plurality of ultraviolet LEDs are spaced equally along a length of the light strip.
Regarding Claim 18, the prior art of record, individually or in combination, does not teach or fairly suggest the system of claim 16, wherein the cladding covers a length of the optical fiber and includes openings formed therein at locations spaced apart along the length of the optical fiber, such that the disinfecting ultraviolet light is emitted from the optical fiber only at the locations. The prior art of record to Tang is considered the closest prior art and describes a device with cladding material but does not describe openings formed along the length of the optical fiber to transmit UV light only at the openings.
Regarding Claim 19, the prior art of record, individually or in combination, does not teach or fairly suggest the system of claim 13, wherein the lighting system comprises: a guide wire; and a light strip mounted on the guide wire, the light strip comprising a plurality of ultraviolet light emitting diodes (LEDs) configured to emit the disinfecting ultraviolet light; wherein the advancement member is configured to advance a portion of the guide wire and the light strip beyond the distal end of the housing. The closest prior art to the claimed invention is Burwell et al. (US 2016/0213945 A1) whom describes a light generating apparatus where a guidewire lumen (98a, Fig. 9C) is disposed adjacent to light source array (97; FIG. 9D shows a linear array 96 including a plurality of light emitting sources that spirals around a guidewire lumen 98b, Para [0081]), but does not describe a light strip mounted on the guide wire having a plurality of ultraviolet LEDs configured to emit disinfecting UV light and configured to move forward a portion of the guide wire and the light strip out of the distal end of the housing.
Regarding Claim 20, the prior art of record, individually or in combination, does not teach or fairly suggest the system of claim 19, wherein the plurality of ultraviolet LEDs are equally spaced along a length of the light strip. The closest prior art to the claimed invention is Burwell et al. (US 2016/0213945 A1) whom describes a light generating apparatus where when a guidewire lumen (98a, Fig. 9C) is disposed adjacent to light source array (97; FIG. 9D shows a linear array 96 including a plurality of light emitting sources that spirals around a guidewire lumen 98b, Para [0081]), but does not describe the plurality of ultraviolet LEDs are spaced equally along a length of the light strip.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E CONLEY whose telephone number is (571)272-8414. The examiner can normally be reached on M-F, 8:30am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN E CONLEY/Primary Examiner, Art Unit 1799